[00:00:00] Speaker 02:
We'll hear argument next in number 19-2372 Pro Farm Inc.

[00:00:06] Speaker 02:
versus Wishta Laboratories Limited.

[00:00:09] Speaker 02:
Mr. Ricciuti.

[00:00:13] Speaker 04:
Thank you, Your Honor, and may it please the Court.

[00:00:16] Speaker 04:
Christopher Ricciuti on behalf of the Appellant Pro Farm.

[00:00:19] Speaker 04:
This appeal stems from two IPRs filed by Appellant where the Board's patentability conclusion rested on two fundamental errors.

[00:00:29] Speaker 04:
The first regarding the board's assessment of the scope and content of the prior art, and the second regarding the board's application of the reasonable expectation of success analysis.

[00:00:39] Speaker 01:
Mr. Ricciuti, before you get into the merits of the appeal, could I ask you to focus for a second on standing and tell us your standing argument?

[00:00:52] Speaker 04:
Yes, Your Honor, thank you.

[00:00:53] Speaker 04:
And that is exactly where I wanted to go first.

[00:00:55] Speaker 04:
There is the threshold issue regarding appellate standing.

[00:00:59] Speaker 04:
And so I think it is appropriate to start there.

[00:01:03] Speaker 04:
On that issue, in view of the party's 10-year negotiation history, WESA's refusal to license these patents to ProFarm and ProFarm's ongoing methylene blue commercial activity, ProFarm has standing to appeal.

[00:01:17] Speaker 02:
WESA's position, contrary to that, is based on two faulty... Why is your commercial activity potentially infringing?

[00:01:27] Speaker 02:
As I understand it,

[00:01:29] Speaker 02:
under the NDA only calls for 97% purity rather than 98% purity.

[00:01:37] Speaker 02:
And I don't see how compliance with the NDA creates infringement or a risk of infringement.

[00:01:48] Speaker 04:
yesterday uh... judge dike so the the fd eight metal blue monograph requires the purity for compliant methylene blue a p i to be at least ninety seven percent pure in the claims require ninety eight percent pure uh... but if i would refer the panel to appendix uh... six six one two a paragraph eighteen that the declaration from mister neumann in this case uh... of pro farm he stayed there that the

[00:02:17] Speaker 04:
Target purity of ProFarm's Methylene Blue API has to exceed 97% to be compliant with the FDA standard.

[00:02:28] Speaker 04:
So certainly, ProFarm goes above 97% in order to ultimately make Methylene Blue API that is-

[00:02:39] Speaker 01:
Doesn't Mr. Newman go further than that?

[00:02:40] Speaker 01:
He points to the 942 and the 850 patents, which he explains cover the method by which you, in fact, make your product.

[00:02:52] Speaker 01:
And both of those

[00:02:54] Speaker 01:
say that the method being used produces a degree of purity greater than 97%, preferably greater than 98% or even better than 99%.

[00:03:06] Speaker 01:
So don't we know from Mr. Newman's declaration that the very process you used, which is detailed in two separate patents,

[00:03:16] Speaker 01:
produces a purity higher than 97% and preferably higher than 98 or 99%.

[00:03:23] Speaker 01:
And doesn't that meet in your mind the minimum threshold for standing?

[00:03:30] Speaker 01:
I mean, I guess it would be hard for me to say, go ahead.

[00:03:33] Speaker 01:
You have to admit you infringe in order to have standing.

[00:03:36] Speaker 01:
That's the hard thing.

[00:03:37] Speaker 01:
You're between a rock and a hard place on that one.

[00:03:40] Speaker 04:
Absolutely, Your Honor, and I think that's exactly right.

[00:03:45] Speaker 04:
There is no requirement to admit to infringement.

[00:03:48] Speaker 04:
Recently, I would point the panel to the court's decision in Mayborn VITC, which is 965 F 1350, where a potentially infringing patent in question was enough to confer appellate standing from

[00:04:04] Speaker 04:
an ITC general exclusion order, and we think the analysis should be the same here for the point exactly that you raise.

[00:04:12] Speaker 04:
We certainly know that Proof Farm's process is capable of making API that exceeds 97%.

[00:04:18] Speaker 04:
The facts are not in the declaration as to in the exact real world commercial embodiment, what that percentage gets up to, whether it's exactly consistent with the patents or not.

[00:04:32] Speaker 04:
But that's exactly our point is that we have a process where the overall methylene blue purity is going to be greater than 97%, so very close at minimum to the claimed 98% purity in order to meet the FDA monograph.

[00:04:52] Speaker 02:
Tell me again, how do we know that it approaches 98%?

[00:04:58] Speaker 04:
The, what Mr. Newman said in Paragraph 18 is that their process has to be... Which page is it?

[00:05:05] Speaker 02:
Which page?

[00:05:06] Speaker 04:
It is APPX 6612 at Paragraph 18.

[00:05:14] Speaker 01:
Well, Council, to be clear, what I was referring you to is at 6613, Paragraph 20, where he explains how your process is actually created by the process described in the 942 and 850, Pat.

[00:05:28] Speaker 01:
And that patent suggests a higher concentration than even his prior paragraph.

[00:05:37] Speaker 04:
Thank you, Judge Moore.

[00:05:38] Speaker 04:
Absolutely it does.

[00:05:40] Speaker 04:
And that is consistent with the prior paragraph and paragraph 18.

[00:05:45] Speaker 04:
My only, I guess, point there was in Mr. Newman's declaration, he hasn't stated exactly how the patent

[00:05:54] Speaker 04:
correlates to the real world ultimate percentage purity of Methylene Blue API.

[00:06:00] Speaker 04:
And so certainly I think the process is capable of exceeding 97%.

[00:06:04] Speaker 04:
No, no, no.

[00:06:07] Speaker 01:
Council, council, council, the process can't be capable of exceeding 90% according

[00:06:12] Speaker 01:
to your patent, it has to exceed 97%.

[00:06:15] Speaker 01:
You have two patents, the 942 and 850.

[00:06:18] Speaker 01:
You say that your commercial product is made by the process articulated in those two patents.

[00:06:25] Speaker 01:
Those two patents don't cover something that might exceed 97%.

[00:06:29] Speaker 01:
They require it to exceed 97%.

[00:06:32] Speaker 01:
What am I missing?

[00:06:34] Speaker 04:
That's correct, Your Honor.

[00:06:36] Speaker 04:
That's correct.

[00:06:38] Speaker 00:
What evidence did you submit that the differences, and it's more than just the methylene blue purity level, that there are other gaps between the FDA requirements and the claims of the patented issue.

[00:06:57] Speaker 00:
So what evidence did you submit that objectively those differences are really meaningless?

[00:07:06] Speaker 04:
This is Judge O'Malley, correct?

[00:07:08] Speaker 00:
Yes.

[00:07:10] Speaker 04:
Thank you.

[00:07:10] Speaker 04:
I know.

[00:07:11] Speaker 00:
I know.

[00:07:11] Speaker 00:
We all sound alike.

[00:07:16] Speaker 04:
When you look at the FDA's requirement, the ASER A and C limits, when you meet the FDA requirement, you're necessarily going to meet the claimed requirements for those impurities.

[00:07:29] Speaker 04:
So the two impurities that we believe are potentially relevant

[00:07:32] Speaker 04:
in terms of potential gaps for standing relate to ASERB and MVB.

[00:07:38] Speaker 04:
The claims say for ASERB less than or equal to 1%, the FDA requirement is less than or equal to 2.5.

[00:07:46] Speaker 04:
And then for MVB, the claims say less than or equal to 0.05%.

[00:07:50] Speaker 04:
The FDA requirement is less than or equal to 0.1%.

[00:07:56] Speaker 04:
And so it's ProFarm's position that, you know,

[00:08:01] Speaker 04:
We're looking at standing here and not the ultimate infringement merits, and it may be the fact that ProFarm's requirement while compliant with the FDA monograph may not ultimately infringe the ASERB or MVB limits, but at this stage when we're talking about standing, those potential gaps shouldn't preclude review, particularly given the fact... So what test would you have us adopt that any time someone

[00:08:30] Speaker 00:
Anytime the FDA requirements are close to the patent limitations, we should say there has to be standing?

[00:08:38] Speaker 04:
Well, I don't know if it needs to be some sort of quantitative look at how close you get to the patent claims themselves.

[00:08:47] Speaker 04:
But looking at what the court said in Mayborn, if you're potentially infringing the patent in question, that should be enough.

[00:08:55] Speaker 04:
And we believe here that where

[00:08:58] Speaker 04:
You necessarily have to meet the Azure A and Azure C limits of WSTAS claims in order to be FDA compliant.

[00:09:06] Speaker 04:
We have a process that absolutely exceeds 97% and per the patents, you know, could be beyond that.

[00:09:16] Speaker 02:
Look at the chart on page 36 of the red brief.

[00:09:20] Speaker 02:
Help us here because they admit that the Azure A and Azure C

[00:09:27] Speaker 02:
requirements are met, but they say that with respect to Azure B and MVB, there's a gap.

[00:09:36] Speaker 04:
What's your answer to that?

[00:09:40] Speaker 04:
The answer there, Your Honor, is that while there may ultimately be a gap in terms of the ultimate infringement proof that we do not believe there needs to be an admission of infringement in order to close that gap for the purposes of standing to get there.

[00:09:55] Speaker 02:
Given that all of... That's true, but we're not talking about admitting infringement.

[00:09:58] Speaker 02:
We're talking about pointing out that your process creates a risk that you would be sued for infringement.

[00:10:06] Speaker 02:
And you've discussed the 97%

[00:10:10] Speaker 02:
as being close to the 98%, but I'm asking about these other two items that apparently there's a gap.

[00:10:19] Speaker 02:
And what did your affiant say, if anything, about whether there was a likelihood that you would come close or exceed these other limitations?

[00:10:36] Speaker 04:
Yes, Your Honor.

[00:10:37] Speaker 04:
And I do not believe that Mr. Newman in his declaration addressed quantitatively how close the process, number-wise, gets to that gap.

[00:10:49] Speaker 01:
But again, I think... Counsel, this is Judge Moore.

[00:10:52] Speaker 01:
Judge Newman said that your products are made by particular patents.

[00:10:56] Speaker 01:
Those patents exceed, articulate a percentage of purity, which exceeds the minimum required by the FDA.

[00:11:04] Speaker 01:
So didn't he, in fact,

[00:11:06] Speaker 01:
give testimony that suggests that your patents and the product it produces are not just at the bare minimum level required by the FDA, but in fact have a greater purity than what's required by the FDA?

[00:11:22] Speaker 04:
And this is where there may be the ultimate disconnect between the patents and what

[00:11:31] Speaker 04:
Mr. Newman said in paragraph 20 of the declaration, appendix 6612 to 6613, that is certainly what the process can do according to that patent and I just don't think the facts exactly are in the record in terms of

[00:11:49] Speaker 04:
what the ultimate API that, for instance, gets incorporated into Prove Blue, the product that's sold in the US, what that purity exactly looks like before it is incorporated into Prove Blue.

[00:12:05] Speaker 00:
What do we do with the fact that, obviously, WIS has been aware of your activities for 10 years.

[00:12:12] Speaker 00:
You say you've been on the market for three years, and there's never been so much as a threat

[00:12:19] Speaker 00:
of an action against you.

[00:12:23] Speaker 04:
And so here I think you have to look at the totality of avert threats and that while there hasn't been an explicit threat, I think it's certainly the circumstances here of tantamount to an avert threat where the parties have engaged in numerous

[00:12:40] Speaker 04:
discussions and disputes over the or negotiations, excuse me, over the past ten years to resolve their underlying patent dispute, it got to the point where the parties were discussing licensing in order to obviate, you know, exactly what we're going through now and potential disputes in the future, and we've deceased all communication and stopped... Well, that's after you threatened them, right?

[00:13:06] Speaker 04:
There was indications that

[00:13:08] Speaker 04:
it if there couldn't be you know certainty so that there would be wouldn't be certainty around the methylene blue business that pro-farm may have to file opposition proceeding offered you a nanopart they would not actually offered it was suggested that that would be their preferred path pro-farm responded saying that that they didn't believe that that would be uh... adequate they wanted uh... at their additional reasons why they thought

[00:13:36] Speaker 04:
a cross license would be better, and then that's when we used to stop communications.

[00:13:42] Speaker 01:
Counsel, I know your time is up, and hopefully Judge Dyke will be generous and restore a little rebuttal time since I'm using part of that time.

[00:13:49] Speaker 01:
But this is Judge Moore.

[00:13:51] Speaker 01:
I have a question.

[00:13:52] Speaker 01:
And the question is, I'm not asking you to admit that the doctrine of equivalence could in fact apply here, because again, that would be like tantamount to admitting, to asking you to admit infringement.

[00:14:03] Speaker 01:
So I'm not doing that.

[00:14:04] Speaker 01:
But isn't it possible that even your process requires you to be higher than 97% which is in fact higher than the FDA guideline and closer therefore to the minimum 98% threshold.

[00:14:18] Speaker 01:
Isn't it possible that say if you're at 97.6 or 97.7 that they could if

[00:14:25] Speaker 01:
if not a literal infringement claim, they could make a claim against you under the doctrine of equivalence.

[00:14:31] Speaker 01:
I mean, to your knowledge, have we ever said that for standing purposes, you have to be within the range for literal infringement?

[00:14:39] Speaker 04:
Not to my knowledge, Your Honor.

[00:14:41] Speaker 04:
I've looked at a lot of the recent standing cases in preparation for today's discussion, and I do not recall that.

[00:14:47] Speaker 04:
And that's certainly a possibility that we could argue if they ultimately file a district court action.

[00:14:54] Speaker 02:
But it's not a possibility that you argued in this case, right?

[00:15:00] Speaker 04:
We... It was not, in the briefing, the doctrine of equivalent's point.

[00:15:05] Speaker 04:
I do not believe so, Judge Dyke.

[00:15:06] Speaker 01:
You argued, didn't you, that they could sue us for infringement, right?

[00:15:11] Speaker 04:
Absolutely.

[00:15:12] Speaker 04:
And that's the basis of our standing argument, is that in view of the totality of the circumstances here,

[00:15:21] Speaker 04:
the threat of an infringement suit is absolutely a possibility given the overlap between the FDA requirements and our patented process and our API manufacturing process.

[00:15:32] Speaker 02:
Unless my colleagues have further questions about standing, I think we'll give you a couple of minutes to discuss the merits.

[00:15:41] Speaker 04:
Absolutely.

[00:15:42] Speaker 04:
Thank you, Your Honor.

[00:15:43] Speaker 04:
So turning to the merits, the first issue regarding the scope and content of the prior art

[00:15:50] Speaker 04:
The point that I would like to make there is that the board collapsed its entire analysis into one perceived mistake in the petition, namely the board's determination that the European pharmacopias and Ackerman's disclosure of a methylene blue percentage did not refer to methylene blue purity.

[00:16:08] Speaker 04:
And while ProFarm does not challenge this finding, we believe that the real error

[00:16:13] Speaker 04:
is the fact that the board ignored the following evidence I'm about to summarize once they identified one error in the petition.

[00:16:21] Speaker 00:
Is it your theory, are you saying that the actual level of purity of those prior art products was irrelevant to the obviousness theory that you asserted in your petition?

[00:16:36] Speaker 04:
No, not that it was irrelevant, but that if there was one petition or position by Prue Farm that the board ultimately disagreed with, that the analysis cannot stop there, and they have to still consider the full petition and the evidence that was put in there and what the true scope and content of the prior art is.

[00:16:56] Speaker 04:
And we're certainly not asking the board to play archaeologist with the record here, but if you look at Wiested Patent itself,

[00:17:04] Speaker 04:
at Appendix 147, Table 3, it states that the starting purity of MedEx Methylene Blue was 93.76% pure.

[00:17:14] Speaker 04:
And then, for example, if you look at DEAN, which was the primary reference that was used in every single ground of unpackability, it reports that the purity of Methylene Blue is 95.4% pure.

[00:17:28] Speaker 04:
This was relied on in the petition at Appendix 216.

[00:17:31] Speaker 04:
And I would also refer the panel to Appendix 767, Lines 8 to 15, where Wiesta's counsel before the PTAB during argument agreed that that 95.4% figure was a purity figure.

[00:17:44] Speaker 04:
So when we're talking about the purity of known methylene blue in the prior art, by the time we get to Wiesta's patent in 2006, it is clear and undisputed that anywhere between 91 and ultimately up to 96%

[00:18:01] Speaker 04:
which I am getting from Appendix 5756 to 5755, which was earlier WISPA testing associated with the UK patent application.

[00:18:12] Speaker 04:
That purity range was known in the prior art.

[00:18:15] Speaker 04:
The scoping content of the prior art was established, and then the only question became a reasonable expectation of success.

[00:18:25] Speaker 00:
to that point, reasonable expectation of success, what was the board supposed to do with all the comments that you've made to patent offices around the world about methylene blue being so hard to purify?

[00:18:39] Speaker 00:
Should those have been ignored?

[00:18:43] Speaker 04:
I don't think those should have been ignored, but they need to be taken in the proper context.

[00:18:49] Speaker 04:
And those statements

[00:18:51] Speaker 04:
were not made in specifically i i believe your honor is referring to the eight fifty patent and uh... european equivalent of the eight fifty patent death uh... and those statements are made in the context of proof or claims where not only did it recite a high level of organic impurity but also a very low level uh... of metallica inorganic impurities which uh... it is not the same case with the independent claims that we suspect

[00:19:19] Speaker 04:
And so those statements were directed at using conventional techniques to get rid of both at the same time, not that if we're simply looking at the independent claim, for example, and we want to purify via HPLC, preparatory HPLC, that is, would there be a reasonable expectation of success?

[00:19:38] Speaker 04:
And so some, in some regards, I think they were comparing

[00:19:41] Speaker 04:
apples to oranges because the claims and the technology was different enough that it would make a meaningful distinction to a person of ordinary skill.

[00:19:52] Speaker 02:
Okay.

[00:19:53] Speaker 02:
I think we're out of time.

[00:19:55] Speaker 02:
We'll give you two minutes for a rebuttal and we'll hear from Mr. Speed.

[00:20:00] Speaker 03:
Thank you, Your Honor.

[00:20:04] Speaker 03:
Good morning, Your Honor.

[00:20:05] Speaker 03:
Nathan Speed on behalf of the Appellee with the Laboratories.

[00:20:08] Speaker 03:
These appeals should be dismissed because the Appellant Proof-of-Farm failed to demonstrate it had standing to bring them.

[00:20:14] Speaker 03:
If, however, the merits are considered, then this Court should affirm because the record amply supports the Board's factual determination and the Board committed no legal errors.

[00:20:22] Speaker 03:
I'll start with the standing issue.

[00:20:26] Speaker 00:
What more do you think that Proof-of-Farm had to allege to establish its standings?

[00:20:34] Speaker 03:
Thank you, Your Honor.

[00:20:35] Speaker 03:
I think in light of the E.I.

[00:20:36] Speaker 03:
DuPont case, the case that Pruitt Farm realized on heavily in its briefing, that type of allegation where in that case DuPont alleged that it had a plant that was operational and had the capability of manufacturing within the claim parameters of the challenged patent, that type of evidence had, if it existed, if Pruitt Farm had submitted that

[00:21:00] Speaker 03:
then that might have been sufficient in light of DuPont to demonstrate standing.

[00:21:05] Speaker 01:
So, Council, this is Judge Moore.

[00:21:09] Speaker 01:
Under the DuPont case, if they had a plant and a process that was capable of infringing, that might be enough.

[00:21:15] Speaker 01:
They expressly allege in their president's Mr. Newman's declaration that they produced their product by virtue of the process in the 942 and 850 patents.

[00:21:27] Speaker 01:
And that process, when you read the patents, produces a product that has greater than 97% purity, preferably greater than 98 or 99% purity.

[00:21:39] Speaker 01:
So why haven't they met the burden that they in fact do have the capability of producing an infringing product by virtue of the process they're using, since that is in fact the preferred embodiment in the patent disclosed that they say they're actually using to produce their product?

[00:21:59] Speaker 03:
Thank you, Your Honor.

[00:22:01] Speaker 03:
A handful of responses there.

[00:22:02] Speaker 03:
One, I believe opposing counsel admitted that there is no connection necessarily between how approval blue is actually manufactured in the real world and how in the preferred environment of the patents.

[00:22:15] Speaker 03:
But more to the point, the patents that are referenced in paragraph 20 of Mr. Newman's declaration relate just to the purity level of methylene blue, but they don't discuss the organic impurities, A or B, AAC,

[00:22:29] Speaker 03:
and MVB that are recited in the WSTA claims.

[00:22:33] Speaker 03:
So the WSTA claims are not just focused on the purity level of methylene blue.

[00:22:38] Speaker 03:
It's the purity level of methylene blue, along with specific purity levels for other organic purities.

[00:22:45] Speaker 03:
And most notably, the WSTA claims require less than 1% of Azure B, whereas the FDA permits Prova Blue to include two and a half times as much of that in purity Azure B.

[00:22:59] Speaker 03:
And so that gap there between the WISTA claims and the FDA requirements for Prova Blue is a sufficient gap to make it an unreasonable allegation of infringement based on the record that we have here.

[00:23:15] Speaker 00:
It's a difference between 1% and 2.5%.

[00:23:17] Speaker 00:
Is that meaningful in the art?

[00:23:21] Speaker 03:
I think we can take Pruba Pharm's own statements to the U.S.

[00:23:24] Speaker 03:
Patent Office and the European Patent Office as to the difficulties associated with using conventional techniques to purify methylene blue and separate it from or purify it from its organic impurities such as Azure B, Azure A, and Azure C. Indeed, to the European office, they told the European office that it was impossible using conventional processes to do that.

[00:23:48] Speaker 00:
I think it's...

[00:23:50] Speaker 00:
What would you have them say, that they are capable of doing all of that?

[00:23:58] Speaker 00:
Is that what they would have to say?

[00:24:00] Speaker 03:
I think going to this court's opinion in the JTKT Corporation decision, they don't need to concede current infringement, but they do

[00:24:12] Speaker 03:
need to establish, quote, that it has concrete plans for future activity that creates a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement.

[00:24:23] Speaker 03:
And so here, had they submitted a declaration that said that they have a plant that is currently capable of producing Provo Blue within the various ranges of the claims of the WISTA patents, that might have been sufficient.

[00:24:38] Speaker 03:
And I think it's important to remember that the burden is on Provo Farm to demonstrate on appeal that it has standing to seek reversal of the board's decisions.

[00:24:49] Speaker 03:
and they have all the information in their possession.

[00:24:52] Speaker 03:
So they either don't actually have the capability to meet the limitations recited in the WISTA patents, or they've made the strategic decision not to introduce the evidence that would establish that, and respectfully, we believe that they should be held to the consequence of that strategic decision, which would be that the appeals are dismissed for lack of standing.

[00:25:12] Speaker 01:
Council, you suggested that one of the problems with their fruit

[00:25:19] Speaker 01:
is that, for example, when it comes to A's or B, one of the organic materials, the claims require it to be at 1% or less.

[00:25:29] Speaker 01:
Is that right?

[00:25:31] Speaker 03:
Correct.

[00:25:32] Speaker 01:
And that they haven't specifically alleged or provided proof that their product is at or less than 1%?

[00:25:42] Speaker 01:
Is that the nature of the argument?

[00:25:43] Speaker 01:
I'm just making sure I understand it.

[00:25:45] Speaker 03:
Correct.

[00:25:47] Speaker 03:
20 of the Newman Declaration just focuses on the methylene blue purity level.

[00:25:53] Speaker 01:
Right, but the two patents that paragraph 20 expressly relies on says the most preferred embodiment has a 99% or a greater than

[00:26:07] Speaker 01:
99% purity of meth blue.

[00:26:11] Speaker 01:
So if the meth blue has to be greater than 99%, doesn't that necessarily exclude one or more percent of Azorb B being included?

[00:26:24] Speaker 01:
I mean, I can count the percent and they got to add up to 100.

[00:26:31] Speaker 03:
That would be correct, Your Honor, if we had any evidence in the record that Prover Farm was manufacturing Prover Blue using that preferred embodiment.

[00:26:42] Speaker 03:
If that was true, it would seem that Prover Farm could have added a paragraph to Dr. Newman's declaration to expressly state as much, and then we wouldn't be in the situation debating about speculating as to what type of process they're using.

[00:26:56] Speaker 03:
This is information... I know.

[00:26:59] Speaker 01:
Please continue.

[00:27:00] Speaker 03:
I was just trying to tell that this is information entirely within their control and they chose strategically to only cite to a patent and suggest that the process is based on that patent without explaining which of the embodied issues.

[00:27:17] Speaker 01:
Go ahead.

[00:27:18] Speaker 01:
Okay, so I have two problems with what you're saying.

[00:27:19] Speaker 01:
Before you just, before you said the standard is

[00:27:24] Speaker 01:
They have to be capable.

[00:27:27] Speaker 01:
Now you're requiring proof that they do, in fact.

[00:27:31] Speaker 01:
And so, I mean, I feel like you've raised the level of proof in response to my very specific question.

[00:27:36] Speaker 01:
So that's kind of point number one.

[00:27:37] Speaker 01:
But point number two that I'd like to raise with you is that paragraph 20 expressly says that they're

[00:27:45] Speaker 01:
preparing proof of blue, or however you call it, based on the process for preparing methylene blue described in the 9-4-2 patent, and then the compound is claimed in the 8-5-0 patent.

[00:27:59] Speaker 01:
And that patent expressly says that the most preferred embodiment is the 99% or greater purity.

[00:28:05] Speaker 01:
So if they're using a process that they have described in detail in a patent as capable

[00:28:15] Speaker 01:
of producing meth blue at greater than 99% purity, why isn't that enough?

[00:28:21] Speaker 01:
You said the standard was capable of.

[00:28:22] Speaker 01:
They said, this is the process we're using.

[00:28:24] Speaker 01:
Here's the patent.

[00:28:25] Speaker 01:
And the patent describes the preferred embodiment as producing greater than 99% purity.

[00:28:30] Speaker 03:
I think, Your Honor, the

[00:28:34] Speaker 01:
The fact that they haven't alleged that they're actually using that preferred embodiment would be... No, but you didn't say, Council, you didn't say they have to allege that they're using that preferred embodiment.

[00:28:44] Speaker 01:
You said our standard, which you were right about, is they're capable of doing it.

[00:28:51] Speaker 03:
They are, Your Honor, so they're capable in the sense of having provided it in their patent specifications, but whether or not they're actually commercially capable of doing it, that's the missing link here.

[00:29:01] Speaker 03:
We don't know if they're actually capable of

[00:29:03] Speaker 03:
achieving those purity levels.

[00:29:06] Speaker 02:
Capable can't be the only test.

[00:29:08] Speaker 02:
There has to be some plan to do something which might infringe.

[00:29:14] Speaker 02:
I mean, anybody could be capable of doing something.

[00:29:19] Speaker 02:
That seems to me perhaps not enough to give you a stand.

[00:29:24] Speaker 03:
I would agree, Your Honor, in this case, just simply by describing.

[00:29:29] Speaker 01:
I would assume you would agree.

[00:29:31] Speaker 01:
There was no actual question in there.

[00:29:33] Speaker 01:
But let's go back to something else.

[00:29:36] Speaker 01:
Why do you think they would spend 10 years negotiating with you over this if they weren't?

[00:29:44] Speaker 01:
planning to or didn't have the capacity to infringe, why would you bother spending if you're really, really close?

[00:29:53] Speaker 01:
Because they are really, really close at a minimum to the bottom threshold because they're using a process which requires the production to be over 97%.

[00:30:03] Speaker 01:
And then their preferred embodiment requires it over 99%.

[00:30:06] Speaker 01:
So just out of curiosity, what do you think would motivate a company to spend 10 years negotiating for a patent license if they weren't capable of infringing?

[00:30:18] Speaker 03:
I would push back on the idea that there's been 10 years of negotiation.

[00:30:22] Speaker 03:
They approached WISTA in 2010 and 2011, which would have been six years before the first WISTA patent even issued.

[00:30:30] Speaker 03:
And they wanted to enter into a business agreement, and Prover Farm and WISTA never reached that agreement.

[00:30:36] Speaker 03:
And then they had no further communications for four years, from 2011 to 2015, when at that point Prover Farm again approached WISTA and the parties had some initial discussions during which Prover Farm sent their draft cross license.

[00:30:47] Speaker 03:
And when WISDA said that they weren't interested in the draft cross license, Proof of Pharmacy's response was to threaten WISDA to encourage them forcefully to enter into the business deal.

[00:30:59] Speaker 03:
And WISDA broke off conversation at that point because they had been threatened.

[00:31:03] Speaker 03:
And then we had these IPRs that were filed.

[00:31:05] Speaker 03:
So there hasn't been a decade's worth of discussions between the parties where these patents were of critical importance.

[00:31:13] Speaker 03:
This has been a story in which Prover Farm has twice reached out to WISDA to try to get Accenture into a business deal with them, and we said no, and their response was to challenge our patents before the PTAB.

[00:31:28] Speaker 02:
Unless there are further questions about standing, perhaps you could take a couple of minutes to address the merits.

[00:31:36] Speaker 03:
Yes, Your Honor.

[00:31:38] Speaker 03:
As the board summarized at pages 19 to 20 of its decision, ProverFarm's petitions were based on two factual pillars.

[00:31:45] Speaker 03:
ProverFarm first alleged that high-purity methylene blue with greater than 98% purity was already known and commercially available as a prior art, and second, that starting with such a high-purity composition, Oppozo would have had a reasonable expectation of success in using conventional HPLC to purify the composition well beyond the claimed ranges.

[00:32:05] Speaker 03:
As the board noted, Prover Farm alleged there would be, quote, nothing challenging with using HPLC to purify methylene blue.

[00:32:11] Speaker 03:
The board correctly found that Prover Farm's arguments suffered from two fundamental and independently dispositive factual flaws.

[00:32:19] Speaker 03:
First, from pages 20 to 32, the board explained that Prover Farm had failed to prove the scope and content of the prior as alleged in the petition.

[00:32:27] Speaker 03:
While Prover Farm cited several references in its petition that disclosed percentages of 98% or greater,

[00:32:33] Speaker 03:
The board found after a detailed assessment of the records that none, not a single one of the percentages actually cited in the petition evidence the existence of high purity methylene blue.

[00:32:43] Speaker 03:
They didn't refer to purity.

[00:32:45] Speaker 00:
The board's analysis... What is your response to their argument, though, that even though that might be the case, the board still should have analyzed all of the prior art cited for purposes of deciding what it did disclose?

[00:33:04] Speaker 00:
even if it didn't disclose exactly what the petition said it did?

[00:33:09] Speaker 03:
Thank you, Your Honor.

[00:33:10] Speaker 03:
The response there would be that within the IPR process, the petitioner has complete control of the petition, and they're bound to the arguments that they actually set forth in the petition.

[00:33:20] Speaker 03:
And there was no distinct argument set forth in their petition that a POSA, rather than starting with high purity methylene blue, would have started with methylene blue of any known purity, and therefore

[00:33:31] Speaker 03:
achieve the purity limitations beside the WISTA claims.

[00:33:35] Speaker 03:
Indeed, page appendix 217, when describing the DEAN reference that Council for approval for arm mentions in its opening argument, they described DEAN's 95.4% pure methylene blue, which would be a specific purity level that was identified in the petition.

[00:33:52] Speaker 03:
They described it as a disadvantageous starting point and then explained that, quote, commercial methylene blue was cheaply available by the time of the invention

[00:34:01] Speaker 03:
at 97 to 99% purity, meaning that purification would have been even easier than at the time of Dean.

[00:34:07] Speaker 03:
And so they clearly premised their entire petition, the scope and content of the prior art, on the existence of high purity methylene blue.

[00:34:17] Speaker 03:
And the contention now that on appeal that they had a more generic argument that was based on simply any specific purity level being known in the art just doesn't

[00:34:27] Speaker 03:
match with what the petition actually said.

[00:34:29] Speaker 03:
Indeed, there's a section in the petition called Contents go for the Prior Art in which they have, on Appendix 225, they explicitly say high purity methylene blue compositions were known.

[00:34:41] Speaker 03:
They talk about those compositions comprising greater than 98%.

[00:34:45] Speaker 03:
They then cite four exhibits, each of which has a percentage that's quoted that's 98 to 103%.

[00:34:51] Speaker 03:
And they conclude that that is

[00:34:53] Speaker 03:
Quote, methylene blue compositions comprising 98% or more were commonly known and suggested in the art.

[00:34:58] Speaker 03:
So that was their petition.

[00:34:59] Speaker 03:
They had complete control of the arguments that they were going to submit in that petition.

[00:35:03] Speaker 03:
And they defined the prior art as having high purity of 98% or more.

[00:35:08] Speaker 02:
OK, but let's assume that they had a starting point around 94, something like that.

[00:35:15] Speaker 02:
Let's assume, just hypothetically, that they had that.

[00:35:19] Speaker 02:
Isn't there a problem with the HPLC

[00:35:23] Speaker 02:
getting you to 98%?

[00:35:28] Speaker 03:
Yes, Your Honor.

[00:35:28] Speaker 03:
And that's the second basis that the board identified in its decision, which was that they failed to prove that conventional HPLC would have allowed you to go from a 94% purity to the claim purity levels recited with this claims.

[00:35:45] Speaker 02:
And my understanding is that they're claiming that the analytic HPLC

[00:35:52] Speaker 02:
would allow you to detect 98% purity?

[00:35:55] Speaker 02:
Am I understanding that correctly?

[00:35:58] Speaker 03:
That is how the board and our expert explain analytical HPLC, which was the basis or what the dean referenced as the basis of their two grounds.

[00:36:11] Speaker 03:
Dean disclosed an analytical process.

[00:36:13] Speaker 03:
So in Proof of Pharm's petition, they pointed to the fractions that are depicted in Dean's figures 6a to 6h and figure 8g, and conclusively stated that those were purified components of methylene blue.

[00:36:27] Speaker 03:
But in reality, as our expert explained and the board agreed,

[00:36:32] Speaker 03:
the fractions actually contain methylene blue combined with an elulate having significantly greater amounts of glycine and other impurities than methylene blue.

[00:36:42] Speaker 03:
That's the board quoting our expert at page 40 of its decision.

[00:36:46] Speaker 03:
So they focused their petition on references that just disclosed an analytical HPLC process and didn't explain how you would go from observing

[00:36:56] Speaker 03:
methylene blue in fractions from an analytical process to actually obtaining isolated pure methylene blue.

[00:37:03] Speaker 03:
And on page 41, they cited to Dr. Sessler, which is expert, who explained that that process going from the fractions in a chromatogram to actually obtaining pure methylene blue was exceptionally difficult, perhaps chemically impossible.

[00:37:20] Speaker 03:
And that's paragraph 134 of his declaration, which they said at page 41.

[00:37:23] Speaker 03:
And that statement from our expert is completely consistent with the position that Prover Farm took before the U.S.

[00:37:29] Speaker 03:
Patent Office, where they said that in 2006, then existing purification techniques inevitably produce impurities, and the position that they took repeatedly in front of the European Office, in which they said that then existing conventional techniques such as HPLC

[00:37:45] Speaker 03:
made it difficult or impossible to actually separate methylene blue or isolate methylene blue from its organic impurities.

[00:37:54] Speaker 02:
Okay.

[00:37:54] Speaker 02:
Unless there are further questions, I think we're out of time.

[00:37:57] Speaker 02:
Hearing none, Mr. Rusciutti, you have two minutes.

[00:38:01] Speaker 04:
Thank you, Judge Dyke.

[00:38:02] Speaker 04:
I would like to make two points on the merits with the remaining time that I have.

[00:38:06] Speaker 04:
The first regarding the scoping content of the prior art and starting methylene blue purity.

[00:38:12] Speaker 04:
If you look at appendix

[00:38:13] Speaker 04:
31, which is the board's final written decision, which quotes directly from Prufarm's petition at appendix 239 to 240, the board summarized our position regarding the scoping content as following.

[00:38:29] Speaker 04:
And that an orderly skilled artisan would have conducted routine experimentation starting with a methylene blue composition such as 95% methylene blue or 99% methylene blue

[00:38:41] Speaker 04:
and ultimately arrived, recited at least 98% methylene blue using HPLC.

[00:38:47] Speaker 04:
That 95% methylene blue is DEAN, that's disclosed in the prior art, and this goes to the board finding what they believe to be one mistake as a higher percentage, 99% being disclosed, and then they stop their analysis there.

[00:39:02] Speaker 04:
They recognize that we said there were lower purities that could be further purified, such as 95%,

[00:39:09] Speaker 04:
And that's Dean, and that gets us to the reasonable expectation of success analysis.

[00:39:14] Speaker 04:
And this is where the board just didn't understand and appreciate ProFarm's argument and the distinction between analytical HPLC and preparatory HPLC.

[00:39:24] Speaker 04:
And you can see this clearly at Appendix 40, where the board states that it credited and agreed with Dr. Sessler's testimony that analytical HPLC process disclosed in Dean would have produced an elutin with impurities other than methylene blue.

[00:39:39] Speaker 04:
uh... the profile never argued otherwise importantly we've never argued that the exact analytical htlc processes that are disclosed indeed would have to be bodily incorporated into the obviousness combination into the hypothetical htlc protocol uh...

[00:39:59] Speaker 04:
to get the successful isolation, what ProForm says is that HPLC is common in the ARC.

[00:40:06] Speaker 04:
In preparatory HPLC, the whole goal is to isolate the methylene, what you are separating out of the HPLC column so that you can then use it.

[00:40:16] Speaker 04:
And with that goal in mind, a person of ordinary skill would have selected

[00:40:21] Speaker 04:
an appropriate noble phase that would have allowed for successful isolation after separation and purification.

[00:40:29] Speaker 04:
When that was rebutted in the patent owner response, by then, by weep to say, well, no, you need to be stuck with exactly what's in Dean.

[00:40:39] Speaker 04:
ProPharm's experts said, okay, even if the obvious misanalysis required that type of plug and chug bodily incorporation, which it doesn't, all you would have to do is look at Dean's Figure 1.

[00:40:52] Speaker 04:
Dean's Figure 1 is a completely volatile mobile phase so that when the solvent, when the thing that comes out of the HPLC column evaporates, you're going to be left with your purified and isolated high purity methylene blue.

[00:41:06] Speaker 02:
That argument... Mr. Ruscha, I think we're out of time.

[00:41:11] Speaker 04:
Apologies, Your Honor.

[00:41:12] Speaker 04:
And thank you.

[00:41:13] Speaker 04:
And so we would ask that the cases be remanded so the board can consider the reasonable expectation of success analysis in view of the full body of prior art.

[00:41:21] Speaker 04:
And thank you very much for the indulgence on extra time this morning.

[00:41:25] Speaker 02:
Okay.

[00:41:26] Speaker 02:
Well, thank you.

[00:41:27] Speaker 02:
Thank both counsel.

[00:41:28] Speaker 02:
The case is submitted.